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Terminated

in2it (I) A1c Test Cartridges (Catalog 281-0001EX) and in2it (II) A1c Test Cartridges (Catalog 281-0001), manufactured by Bio-Rad Laboratories Deeside Ltd., Flintshire, UK, distributed by Bio-Rad Laboratories, Hercules, CA. The in2it (I) is for Physician use, the (II) is for prescription home use. The products are medical devices used in affinity chromatography method, intended for the in-vitro quantitative determination of A1c (HbA1C) in capillary blood taken from a finger prick. The test is indicated for monitoring the time averaged blood glucose levels of known diabetics, for professional use as an indicator of overall glycemic control.

FDA Recall Z-0109-2011 · Posted 2010-10-21

Recalling FirmBio-Rad Laboratories Inc
Recall StatusTerminated
Product CodeLCP
Date Initiated2010-09-07
Date Terminated2011-05-17
Product Quantity4056

Reason for Recall

Test Cartridges may leak and have the potential to generate error messages and biased inaccurate results.

Firm Action

BIO-RAD Laboratories Deeside sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated September 7, 2010, via registered mail to all subsidiaries/customers. The letter described the product, problem and actions to be taken by the customer. The customers were instructed to stop using and discard the test cartridges from the listed lots; complete and return the attached CUSTOMER MEDICAL DEVICE CORRECTION RESPONSE FORM via fax +44 1244 833401; record the number of affected kits of product, confirm that they have discarded the cartridges and record the method of disposal. If you have any questions, contact +44 1244 288888.

Root Cause

Component design/selection

Distribution Pattern

Worldwide distribution: USA and countries including: Australia, New Zealand, Taiwan, France, the UK, Singapore, Germany, Italy, Thailand, China, Korea, Sweden, Sri Lanka, Maldives, Canada and the Philippines.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041635G5 I HBA1C TEST, G5 II HBA1C TESTProvalis Diagnostics , Ltd. · 2004-08-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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